Which type of site will you recruit from?
We will be recruiting patients from acute NHS Trusts and Health Boards in the UK that admit and manage patients with acute variceal bleeding.
Has a recruitment target been confirmed?
The recruitment target is 294 patients across 30 sites in the UK. We expect sites to recruit three or more participants per year. If this is not possible, please do reach out to the team to discuss further with the CI.
When is the recruitment end date?
28/02/2028.
When is the end date for the study activities? (i.e. “last patient visit” completed and study is ready to be archived.)
28/08/2029.
The dates provided above have been projected based upon the first site opening. Please note that the trial has an internal pilot (1 year) and any decision going forward will be based on how the pilot goes and if we move to full trial. For further information regarding the progression criteria for the pilot, please see section 2.1 of the Protocol.
Has the study been adopted by the CRN?
Yes.
Is there any pharmacy/ CRF/ CRF labs involvement?
There is no CRF/Labs/pharmacy involvement. The main delivery team is imaging.
Will blood samples be sent to the trial’s office?
No, these will be classed as standard of care and sites will only be required to record the results onto the CRF.
Can you confirm that all blood tests taken are standard of care and there is no requirement for any additional local lab processing?
Yes. Blood tests are standard of care and there is no requirement for any additional local lab processing.
Which blood tests do I need to record on the Baseline CRF?
We advise that the most recent standard of care bloods are used within a 48h timeframe prior to randomisation.
Are any devices to be provided for the study?
No devices are required or will be provided for the trial.
Does this trial require ARSAC approval?
No. Radiation Assurance approval is in place and will be provided to all sites within their Local Information Pack.
Will staff only perform a diagnostic endoscopy if there is suspected bleeding, or can there be other reasons a diagnostic endoscopy has been performed?
Whilst the index endoscopy will be performed due to a history of bleeding, subsequent endoscopies may be carried out for several reasons i.e. where bleeding is suspected, as part of the banding programme in the SoC arm, or if there is a crossover from SoC to the TIPSS arm.
Does a patient have to be actively bleeding at the time of endoscopy?
No.
Which members of staff need to be listed on the delegation log? Should the Radiologist and Anaesthetist performing the TIPSS procedure be included?
The research staff listed on the delegation log should be those who are able to undertake the tasks outlined in the log. It is the responsibility of the PI to confirm that those that are listed on the delegation log are qualified to undertake such activities. All tasks listed on the delegation log must be covered by at least one member of staff at a site for Green Light approval to be granted. We do suggest that sites may want to add sub-investigators (for if the PI is not available) and ideally a senior gastroenterology/hepatology colleague. This is particularly important when covering causality review during adverse event reporting. As the TIPSS procedure is carried out within routine care, an interventional radiologist/ITU consultants/ anaesthetist is not required on the delegation log.
For the Associate PI Scheme, can there be two or more simultaneous Associate PI (aPI) Trainees who are amid their 6-month tenure, at the same site, at the same time?
Most PIs will only mentor one aPI Trainee at a time. However, if you as the local PI are happy to mentor more than one aPI Trainee at a time then NIHR will allow this. We are led by the capacity of the local PI. If a site has the capacity to support multiple aPIs, please contact the BCTU trial office to confirm and we will inform the NIHR team.
What training is involved to participate in the REACT-AVB trial?
The Research Team are required to watch the pre-recorded Site initiation Training slides. The PI and aPI (if one appointed) are also required to attend a Q& A session after watching the pre-recorded video. We will encourage the rest of the team to attend the Q&A session, but this is not mandatory.